COMPUTER SYSTEM VALIDATION [CSV]

Sorry, registration has ended.

Overview
CSV (Computer System Validation) is the process of ensuring that any technology component
(software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain
industry. It is especially crucial in FDA / EU-regulated industries like biotech and pharma, since
products from these sectors impact public health and safety.
Why Computer System Validation?
A validation assessment program is a necessity in the pharma industry to ensure adherence
to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same
principles are applied in computer system validation to a computer system or an information
technology system.
It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching
consequences. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed.